Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
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Who Should Attend
The course will benefit those involved in testing pharmaceutical,
medical device and biotechnology products, especially:-
QA/QC Personnel
- Laboratory Managers
- Analysts
- Senior Technicians
It will be of particular value to those involved in the
establishment of new programs and to those who have
recently started work and management in this area. The
course will also benefit those concerned about endotoxin
contamination of tissue culture media.
Description
The aim of this course is to give you a full understanding of
the bacterial endotoxins test, including principles, practice,
limitations and regulatory considerations. Endotoxins are
recognized as being by far the most significant pyrogen, but
they are often poorly understood. LAL testing for the
presence of endotoxins is an established procedure in the
manufacture of products that enter the blood stream. The
course covers the nature of endotoxins and the implications
of their biochemical properties for the LAL test and cell
cultures. The principles of the various LAL methodologies are
given and the advantages/disadvantages of each are
considered. Strategies for overcoming and avoiding problems
are explained. The course examines the FDA Guideline on
LAL Testing and the USP Bacterial Endotoxins Test with a
view to writing SOPs for LAL testing. The value of in-process
testing is stressed.